CPG 7909 in Patients With Cutaneous T-Cell Lymphoma

NCT ID: NCT00043420

Last Updated: 2009-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the effect of CPG 7909 Injection on Cutaneous T-cell lymphoma and the safety of CPG 7909 Injection in patients with this cancer.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lymphoma, T-Cell, Cutaneous

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phase I: 0.08 mg/kg

Escalating dose groups: 0.08 mg/kg PF-3512676 Injection

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 0.08mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Phase I: 0.16 mg/kg

Escalating dose groups: 0.16 mg/kg PF-3512676 Injection

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 0.16mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Phase I: 0.24 mg/kg

Escalating dose groups: 0.24 mg/kg PF-3512676 Injection

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 0.24mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Phase I: 0.28 mg/kg

Escalating dose groups: 0.28 mg/kg PF-3512676 Injection

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 0.28mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Phase I: 0.32 mg/kg

Escalating dose groups: 0.32 mg/kg PF-3512676 Injection

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 0.32mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Phase I: 0.36 mg/kg

Escalating dose groups: 0.36 mg/kg PF-3512676 Injection

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 0.36mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Phase II: 10 mg

Phase II: 10 mg flat dose (random assignment in Phase II)

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 10 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Phase II: 25 mg

Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Group Type EXPERIMENTAL

PF-3512676

Intervention Type DRUG

Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-3512676

Weekly subcutaneous injections of 0.08mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

PF-3512676

Weekly subcutaneous injections of 0.16mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

PF-3512676

Weekly subcutaneous injections of 0.24mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

PF-3512676

Weekly subcutaneous injections of 0.28mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

PF-3512676

Weekly subcutaneous injections of 0.32mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

PF-3512676

Weekly subcutaneous injections of 0.36mg/kg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

PF-3512676

Weekly subcutaneous injections of 10 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

PF-3512676

Weekly subcutaneous injections of 25 mg PF-3512676. Treatment continues for a minimum of 8 weeks unless disease progression or unacceptable toxicity occurs, or a maximum of 24 weeks.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ProMune, CPG 7909 ProMune, CPG 7909 ProMune, CPG 7909 ProMune, CPG 7909 ProMune, CPG 7909 ProMune, CPG 7909 ProMune, CPG 7909 ProMune, CPG 7909

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients 18 years or older with biopsy (histopathologically) confirmed cutaneous T-cell lymphoma (limited to mycosis fungoides (MF)) who have had prior therapy with at least one and no more than 3 systemic treatments.

Exclusion Criteria

Patients with visceral involvement, serious infection or illness including human immunodeficiency virus infection, or a Karnofsky Performance Status (KPS) \< 60 will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pfizer, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

References

Explore related publications, articles, or registry entries linked to this study.

Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

Reference Type DERIVED
PMID: 32632956 (View on PubMed)

Kim YH, Girardi M, Duvic M, Kuzel T, Link BK, Pinter-Brown L, Rook AH. Phase I trial of a Toll-like receptor 9 agonist, PF-3512676 (CPG 7909), in patients with treatment-refractory, cutaneous T-cell lymphoma. J Am Acad Dermatol. 2010 Dec;63(6):975-83. doi: 10.1016/j.jaad.2009.12.052.

Reference Type DERIVED
PMID: 20888065 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CO14, A8501014

Identifier Type: -

Identifier Source: secondary_id

C014

Identifier Type: -

Identifier Source: org_study_id

NCT00091208

Identifier Type: -

Identifier Source: nct_alias

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Disseminated High Grade Lymphoma
NCT00536393 COMPLETED PHASE2/PHASE3
Anti-Tac for Treatment of Leukemia
NCT00001941 COMPLETED PHASE1/PHASE2